Principal Scientific Adviser to GoI reviews progress to transform India’s regulatory ecosystem for medical products

Prof. Ajay Kumar Sood, Principal Scientific Adviser (PSA) to the Government of India took a meeting to review the progress made towards transformation of India’s regulatory system. This matter was discussed in the 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting, chaired by the PSA, and held on the 6th of February 2024 on ‘Transforming the regulatory ecosystem of the medical products in India’. The PM-STIAC meeting had recommended comprehensive overhauling of the regulatory processes and working towards building a system that ensures transparency, accountability and at the same time promotes innovation and introduction of safe and affordable medical products for India and the world.

Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO) updated the progress in priority areas identified as part of the PM-STIAC meeting, such as streamlining of the Subject Expert Committee (SEC) review process and internal process improvement with the help of an independent external agency. He also elaborated on the development of an end-to-end digital architecture for the transformation of India’s regulatory ecosystem, consolidation of Review Committee on Genetic Manipulation (RCGM) activities to a single window system thereby reducing the timeline of approvals, developing the scientific capacity of CDSCO, increased digitization, and the recent notification of countries under Rule 101 to simplify access to medical products, among others.

PSA Prof. Sood appreciated the efforts of CDSCO and emphasized that a robust and enabling regulatory ecosystem will help to build trust in domestic and international markets, boost manufacturing and exports. He said that these efforts will further augment the competitive advantage that India has in the manufacturing of medical products and spur innovations in the entire sector.